Intraocular Pressure, Blood Pressure, Ocular Perfusion and Blood Flow Fluctuations in Glaucoma Patients

Open Angle Glaucoma Clinical Trial

Official title:

Comparison of Intraocular Pressure, Blood Pressure, Ocular Perfusion and Blood Flow Fluctuations During the Addition of Dorzolamid vs Timolol in Glaucoma Subjects Treated With Prostaglandin Analogue Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304264
• Other study ID #: 37552
• Status: Completed
• Phase: N/A
• First received: February 24, 2011
• Last updated: January 11, 2012
• Start date: March 2011
• Est. completion date: November 2011

Study information

• Verified date: January 2012
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lithuania: Bioethics Committee
• Study type: Observational

Clinical Trial Summary

To evaluate whether add-on to prostaglandin therapy with twice a day (bid) dorzolamide is statistically superior to twice a day (bid) timolol with regard to increasing ocular blood flow

Description:

Hypotensive treatments for glaucomatous optic neuropathy (GON), depending on their chemical composition can influence the ocular circulation independent of intraocular pressure (IOP) reduction. It is therefore important not only to identify ocular blood flow deficits in GON, but also document the influence of GON treatments on the ocular circulation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Open angle glaucoma subjects receiving prostaglandin monotherapy in both eyes

Exclusion Criteria:

• younger than 18 years old

• women of child bearing potential

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma

Intervention

Device:
• Color Doppler Imaging
Color Doppler imaging (CDI) system for measurements of blood flow in the ophthalmic (OA), central retinal (CRA), and nasal (NPCA) and temporal (TPCA) posterior ciliary arteries. In each vessel, peak systolic velocity (PSV) and end diastolic velocity (EDV) were determined, and Pourcelot's resistive index will be calculated (RI = (PSV-EDV)/PSV).

Locations

Country	Name	City	State
Lithuania	Eye Clinic Lithuania Health Science Hospital Kaunas Clinics	Kaunas

Sponsors (3)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences	Indiana University School of Medicine, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Color Doppler Imaging	Color Doppler Imaging; Nasal post ciliary artery (NPCA); Temporal posterior ciliary artery (TPCA); Ophthalmic artery (OA); Central retinal artery (CRA)	8 AM; 8 PM	No
Secondary	IOP, BP, OPP (mean, fluctuations, amplitude)	IOP, BP, OPP (mean, fluctuations, amplitude) Goldmann applanation tonometry Brachial artery pressure and radial pulse	8 AM-12AM-4PM-8PM	No